FDA Rejects Alkermes Depression Drug, Asks for More Clinical Data

The FDA has rejected a depression drug from Alkermes, unpersuaded that the company’s experimental treatment actually works.

Alkermes said Friday afternoon that the FDA’s letter asked the company for additional clinical data “to provide substantial evidence of effectiveness” for the drug, ALKS 5461. The company, which is based in Dublin, Ireland, and maintains a large presence in Waltham, MA, said it plans to meet with the FDA to discuss the regulator’s concerns.

Shares of Alkermes (NASDAQ: ALKS) dipped nearly 5 percent to $31.50 in after-hours trading.

The Alkermes drug, ALKS 5461, was developed as a treatment for patients whose major… Read more »





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